Pharmacokinetics and pharmacodynamics during treatment with the omeprazole 20 mg enteric-coated tablet and 20 mg capsule in asymptomatic duodenal ulcer patients.
This study compared the 24 h intragastric pH profile and bioavailability at repeated dosing conditions of the omeprazole 20 mg enteric-coated tablet versus the 20 mg capsule. Forty duodenal ulcer patients in asymptomatic remission completed this randomized open two-way crossover study. Omeprazole 20 mg tablets or capsules were administered for seven days in each period. A 24 h pH recording was performed before the start of treatment and on day 7 of each treatment period. Plasma concentrations of omeprazole were determined 24 h after the dose. The treatment periods were separated by two to four weeks. The difference in percentage of time with pH of at least 3 was less than 16% in favour of the tablet (not significant). The estimated mean area under the plasma concentration-time curve as well as the maximum plasma concentration (Cmax) for omeprazole were 18% and 41% higher, respectively, for the tablet versus the capsule, with the latter percentage being statistically significant. The time to reach Cmax (tmax) with the tablet was, on average, about 0.5 h longer than to reach the tmax of the capsule. This study indicates that the enteric-coated tablet formulation of omeprazole is biodynamically equivalent to the capsule regarding their effects on intragastric pH during repeated dosing.
Thomson
A B
AB
Division of Gastroenterology, University of Alberta, Edmonton. alan.thomson@ualberta.ca
Kirdeikis
P
P
Lastiwka
R
R
Röhss
K
K
Sinclair
P
P
Olofsson
B
B
D000328:Adult; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics / Q000494:pharmacology; D019540:Area Under Curve; D001682:Biological Availability; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D004381:Duodenal Ulcer / Q000188:drug therapy*; D005260:Female; D005744:Gastric Acid / Q000378:metabolism; D006801:Humans; D006863:Hydrogen-Ion Concentration; D016014:Linear Models; D008297:Male; D008839:Microelectrodes; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics / Q000494:pharmacology; D013608:Tablets, Enteric-Coated; D013810:Therapeutic Equivalency; D013997:Time Factors
D000897:Anti-Ulcer Agents; D002214:Capsules; D013608:Tablets, Enteric-Coated; D009853:Omeprazole